NIGHTWATCH(TM) SYSTEM— 510(k) K870578

Name: FDA 510(k) clearance K870578
Creator: U.S. Food and Drug Administration
Published: 1987-06-29

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K870578 for NIGHTWATCH(TM) SYSTEM, Substantially Equivalent on 1987-06-29. Applicant: Buckman Co., Inc.. Device class: 2.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1987-02-10
Decision date: 1987-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSH

view all

K260157 — LifeLens Physiological Monitor2026-07-09
K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)2026-04-23
K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

More clearances from Buckman Co., Inc.

view all

K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM1998-06-25
K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM1998-06-08
K964252 — ORTHOCHUCK1997-05-27
K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM1997-01-16
K960451 — WEBB-MORLEY SPINE SYSTEM1996-04-18

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.